Class III
Terminated
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
This recall has been terminated (originally issued November 30, 2022).
- Company
- Acella Pharmaceuticals, Llc
- Recall Initiated
- November 14, 2022
- Posted
- November 30, 2022
- Recall Number
- D-0070-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 637 cartons
- Firm Location
- Alpharetta, GA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot: E026A001 Exp. 06/2023
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